Quality Systems

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

Articles

This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data. 

Determining the Best Estimate of Probability of Passing Multiple Stage Tests:  Part 1–Content Uniformity

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies. 

Responding to FDA CAPA Requests 

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Computerized System Descriptions–How Hard Can It Be?

Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

Waters and Genovis to Collaborate on Biopharmaceutical Characterization Workflows

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

FDA Unveils Extensive Manufacturing Violations at Emergent

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Hyalo Technologies Unveils Room Temperature Drug-Stabilizing Technology

Kalah Auchincloss, senior vice-president and deputy general counsel, Greenleaf Health, Inc.

This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.

FDA Inspections During COVID-19: A Brave New World

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

FDA Inspectors Cited Critical Problems at Emergent Facility

Editor of Pharmaceutical Technology Europe

After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.

Blocking the Threat of Counterfeit Medicines

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Steven J. Lynn is executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding deviation investigations.

Quality Assurance/Quality Control